Hip InjuriesNCT05120063
Benefit of 3-D Planning in Total Hip Replacement. A Prospective Randomized Study
A study testing SPS monoblock stem, Symbios, Quadra-H, Medacta and 3D planning of THR in people with Hip Injuries and Surgery, run by Balgrist University Hospital.
Trial summary
In this prospective randomized four-armed study the investigators aim to compare wheter 3-D planning, which necessitates preoperative CT acquisition and sophisticated planning together with engineers, results in measurable benefits in terms of objective and subjective outcome values in a collective of patients… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hip Injuries, Surgery, Prosthesis User
- What is being tested?
- SPS monoblock stem, Symbios, Quadra-H, Medacta and 3D planning of THR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2012to 28 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 40-70 years scheduled for primary THR
- signed written informed consent.
Who cannot join
- Charnley class B and C
- ASA score >2
- pregnancy
- gross hip deformity making complex hip reconstruction (greater trochanter advancement, acetabular augmentation, femoral osteotomy, use of cemented or revision stem) necessary
- immature patients and patients incompetent to judge
About this study
In this prospective randomized four-armed study the investigators aim to compare wheter 3-D planning, which necessitates preoperative CT acquisition and sophisticated planning together with engineers, results in measurable benefits in terms of objective and subjective outcome values in a collective of patients undergoing primary total hip replacement.
Hypothesis:
- When compared to 2-D planning, 3-D planning of a THR results in better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.
- When compared to a non-anatomical stem, an anatomical stem allows better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.
Read the detailed description
Patients sent to our outpatient clinic for eventual primary THR are informed about this study and written patient information given to them. When patients decide to undergo primary total hip replacement, patient's questions with respect to this study are discussed in the outpatient clinic and patients willing to participate included.
Block randomization using closed envelopes for age categories 40-50, 50-60, 60-70 years will be conducted to assign the participant to one of the four study arms.
Patients will be blinded for the type of stem and method of planning. Investigators are blined in terms of methods of planning. In terms of stem design, investigators can not be blinded since their visibility on x-ray does not allow it.
The preoperative investigation includes routine investigation and an additional CT scan plus evaluation of the "University of California at Los Angeles" (UCLA) activity level and "Short Form Health 36" (SF-36) score. The same applies for the postoperative investigation and 3 months. The follow-up visits at 1, 5 and 10 years are routine investigations with additional UCLA and SF-36 Scores.
- Conditions
- Hip Injuries, Surgery, Prosthesis User
- Being tested
- SPS monoblock stem, Symbios, Quadra-H, Medacta, 3D planning of THR, 2D planning of THR
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPS monoblock stem, SymbiosDevice
hip prosthesis
Quadra-H, MedactaDevice
hip prosthesis
3D planning of THRProcedure or surgery
primary total-hip replacement (THR) planned on 3-dimensional images (computer tomography)
2D planning of THRProcedure or surgery
primary total-hip replacement (THR) planned on 2-dimensional images (anteroposteiros pelciv x-ray)
| Study group | Role | What they receive |
|---|---|---|
| 3D anatomical stem | Experimental | 3-D-Planing with anatomical stem (SPS monoblock stem, Symbios) Receives: Device: SPS monoblock stem, Symbios; Procedure: 3D planning of THR |
| 3D non-anatomical stem | Experimental | 3-D-Planing with non anatomical stem (Quadra-H, Medacta) Receives: Device: Quadra-H, Medacta; Procedure: 3D planning of THR |
| 2D anatomical stem | Experimental | 2-D-Planing with anatomical stem (SPS monoblock stem, Symbios) Receives: Device: SPS monoblock stem, Symbios; Procedure: 2D planning of THR |
| 2D non anatomical stem | Experimental | 2-D-Planning with non anatomical Stem (Quadra-H, Medacta) Receives: Device: Quadra-H, Medacta; Procedure: 2D planning of THR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients, including pain, stiffness, and physical functioning of the hip.
A difference in WOMAC of 2.5 points is considered relevant. 3-D-planing and/or anatomical stems will be considered superior to 2-D-planing and /or non-anatomical stems if the one year WOMAC significantly differs by 2.5.
Measured: Change from basline to one year
Change in subjective hip value (SHV)
The subjective hip value (SHV) is as a patient-reported outcome measurement (PROM) which is reported by the patient. It is easily and quickly performed and interpreted. The SHV is defined as a patient's subjective hip satisfaction expressed as a percentage of 100%, which is the score that an entirely normal hip joint would reach.
A difference in subj. hip value of 25% is considered relevant. 3-D-planing and/or anatomical stems will be considered superior to 2-D-planing and /or non-anatomical stems if the one year subjective hip value significantly differs by 25%.
Measured: Change from basline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Jun 2012
- Primary completion28 Jan 2030 (estimated)
- Study completion28 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Symbios Orthopedie SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120063
- Sponsor's protocol ID
- KEK Nr. 2012-0064
- Status last verified
- Aug 2023
- First submitted
- 6 May 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of 3-D Planning in Total Hip Replacement. A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05120063
- Acronym / sponsor ID
- KEK Nr. 2012-0064
- Conditions
- Hip Injuries, Surgery, Prosthesis User
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Symbios Orthopedie SA
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 28 Jan 2030 (estimated)
- Study completion
- 28 Jan 2030 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective randomized four-armed study the investigators aim to compare wheter 3-D planning, which necessitates preoperative CT acquisition and sophisticated planning together with engineers, results in measurable benefits in terms of objective and subjective outcome values in a collective of patients undergoing primary total hip replacement.
Hypothesis:
- When compared to 2-D planning, 3-D planning of a THR results in better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.
- When compared to a non-anatomical stem, an anatomical stem allows better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.
Detailed description
Patients sent to our outpatient clinic for eventual primary THR are informed about this study and written patient information given to them. When patients decide to undergo primary total hip replacement, patient's questions with respect to this study are discussed in the outpatient clinic and patients willing to participate included.
Block randomization using closed envelopes for age categories 40-50, 50-60, 60-70 years will be conducted to assign the participant to one of the four study arms.
Patients will be blinded for the type of stem and method of planning. Investigators are blined in terms of methods of planning. In terms of stem design, investigators can not be blinded since their visibility on x-ray does not allow it.
The preoperative investigation includes routine investigation and an additional CT scan plus evaluation of the "University of California at Los Angeles" (UCLA) activity level and "Short Form Health 36" (SF-36) score. The same applies for the postoperative investigation and 3 months. The follow-up visits at 1, 5 and 10 years are routine investigations with additional UCLA and SF-36 Scores.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3D anatomical stem | Experimental | Device: SPS monoblock stem, Symbios, Procedure: 3D planning of THR3-D-Planing with anatomical stem (SPS monoblock stem, Symbios) |
| 3D non-anatomical stem | Experimental | Device: Quadra-H, Medacta, Procedure: 3D planning of THR3-D-Planing with non anatomical stem (Quadra-H, Medacta) |
| 2D anatomical stem | Experimental | Device: SPS monoblock stem, Symbios, Procedure: 2D planning of THR2-D-Planing with anatomical stem (SPS monoblock stem, Symbios) |
| 2D non anatomical stem | Experimental | Device: Quadra-H, Medacta, Procedure: 2D planning of THR2-D-Planning with non anatomical Stem (Quadra-H, Medacta) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 40-70 years scheduled for primary THR
- signed written informed consent.
Key exclusion criteria (5 listed)
- Charnley class B and C
- ASA score >2
- pregnancy
- gross hip deformity making complex hip reconstruction (greater trochanter advancement, acetabular augmentation, femoral osteotomy, use of cemented or revision stem) necessary
- immature patients and patients incompetent to judge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPS monoblock stem, Symbioship prosthesis | Device | 2D anatomical stem, 3D anatomical stem |
| Quadra-H, Medactahip prosthesis | Device | 2D non anatomical stem, 3D non-anatomical stem |
| 3D planning of THRprimary total-hip replacement (THR) planned on 3-dimensional images (computer tomography) | Procedure or surgery | 3D anatomical stem, 3D non-anatomical stem |
| 2D planning of THRprimary total-hip replacement (THR) planned on 2-dimensional images (anteroposteiros pelciv x-ray) | Procedure or surgery | 2D anatomical stem, 2D non anatomical stem |
Primary outcome
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Change from basline to one year
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients, including pain, stiffness, and physical functioning of the hip. A difference in WOMAC of 2.5 points is considered relevant. 3-D-planing and/or anatomical stems will be considered superior to 2-D-planing and /or non-anatomical stems if the one year WOMAC significantly differs by 2.5.
Change in subjective hip value (SHV)
Time frame: Change from basline to one year
The subjective hip value (SHV) is as a patient-reported outcome measurement (PROM) which is reported by the patient. It is easily and quickly performed and interpreted. The SHV is defined as a patient's subjective hip satisfaction expressed as a percentage of 100%, which is the score that an entirely normal hip joint would reach. A difference in subj. hip value of 25% is considered relevant. 3-D-planing and/or anatomical stems will be considered superior to 2-D-planing and /or non-anatomical stems if the one year subjective hip value significantly differs by 25%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SPS monoblock stem, Symbios, Quadra-H, Medacta and 3D planning of THR in people with Hip Injuries and Surgery, run by Balgrist University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: Change from basline to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.